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Cardiovascular Devices News

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106-120 of 2729 results
Baron & Budd probes potential lawsuits involving severe complications tied to defective equipment used during open-heart surgeries
The national law firm of Baron & Budd is investigating potential lawsuits against the manufacturers of heater-cooler devices used during many open-heart surgeries.
Specialty Devices > Cardiovascular Devices > News
St. Jude, Abbott to divest vascular products to Terumo for $1.12bn
St. Jude Medical and Abbott have agreed in principle to divest some of their cardiovascular products to Japanese firm Terumo for about $1.12bn.
Specialty Devices > Cardiovascular Devices > News
US CDC issues infection warning for devices used in open heart surgery
The US Centers for Disease Control and Prevention (CDC) has warned that open heart surgery patients are at the risk of bacterial infection due to the contamination of certain heater-cooler devices.
Specialty Devices > Cardiovascular Devices > News
Neural Analytics begins study to assess new diagnostic platform for early detection of stroke
Neural Analytics has started the clinical study to assess next generation portable diagnostic platform for early detection of stroke.
Specialty Devices > Cardiovascular Devices > News
BioStable Science seeks FDA approval for HAART 300 aortic annuloplasty device
Cardiovascular device company BioStable Science & Engineering is seeking approval from the US Food and Drug Administration (FDA) for its HAART 300 aortic annuloplasty device.
Specialty Devices > Cardiovascular Devices > News
Heart Test Labs completes regulatory submission for FDA 510(k) and CE mark
Heart Test Laboratories has announced that it has submitted its 510(K) application to the Food and Drug Administration (FDA) and a CE Mark certification submission to the British Standards Institute (BSI) group for its MyoVista electrocardiographic device.
Specialty Devices > Cardiovascular Devices > News
Medtronic reports one-year clinical trial results of Avalus surgical aortic valve
Medtronic has announced positive clinical data for its investigational Avalus pericardial aortic surgical valve, intended for the treatment of aortic valve disease.
Specialty Devices > Cardiovascular Devices > News
FDA classifies two field actions related to HeartWare HVAD system as class 1 recalls
Medtronic announced that two previously communicated global voluntary recalls related to the HeartWare International (HeartWare) HVAD System have been classified as Class 1 by the U.S. Food and Drug Administration (FDA).
Specialty Devices > Cardiovascular Devices > News
Philips partners with World Heart Federation to prevent cardiovascular disease
Royal Philips announced a new partnership with the World Heart Federation (WHF) to help people better manage their heart health.
Specialty Devices > Cardiovascular Devices > News
Edwards Lifesciences wins CE mark approval for Inspiris Resilia aortic valve
By MDBR Staff Writer
Edwards Lifesciences has received CE mark approval for its Inspiris Resilia aortic valve to treat heart valve patients.
Specialty Devices > Cardiovascular Devices > News
SentreHEART announces closing of $35m funding round for aMAZE trial
SentreHEART, the manufacturer of the LARIAT technology for catheter-based, non-implant left atrial appendage closure (LAAC), announced it has closed a $35m Series D round of financing.
Specialty Devices > Cardiovascular Devices > News
Claret Medical seeks FDA approval for Sentinel cerebral protection system
By MDBR Staff Writer
Claret Medical is seeking approval from the US Food and Drug Administration (FDA) for its Sentinel cerebral protection system (CPS).
Specialty Devices > Cardiovascular Devices > News
Versa Capital buys US medical technology firm SynCardia Systems
By MDBR Staff Writer
Versa Capital Management has acquired US medical technology company SynCardia Systems for an undisclosed sum.
Specialty Devices > Cardiovascular Devices > News
Boston Scientific’s new Lotus Edge valve system wins CE mark approval
By MDBR Staff Writer
Boston Scientific has secured CE mark approval for its Lotus Edge valve system, which is indicated to replace aortic valve in patients with serious aortic stenosis who are considered at high risk for surgical valve replacement.
Specialty Devices > Cardiovascular Devices > News
Shockwave's Lithoplasty system gets FDA approval to treat calcified peripheral artery disease
By MDBR Staff Writer
Shockwave Medical has secured approval from the US Food and Drug Administration (FDA) for its Lithoplasty system to treat calcified plaque in peripheral artery disease (PAD) patients.
Specialty Devices > Cardiovascular Devices > News
106-120 of 2729 results